BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: THERMISTOR 7.5 110CM

    MDR report key: 4070968 · Received August 29, 2014

    Report

    Report Number
    3010532612-2014-00016
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Date of Event
    July 16, 2014
    Report Date
    August 15, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K833918
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT WHO ARRIVED WITH A GUNSHOT INJURY. WHILE IN THE INTENSIVE CARE UNIT THE DOCTOR INSERTED THE CATHETER AND THE PWP (PULMONARY WAVE PRESSURE) DIDN'T APPEAR ON THE MONITOR. AS A RESULT, THE CATHETER WAS REMOVED AND THEY REALIZED THAT THE "BALLOON WAS RIPPED." THE MD USED ANOTHER CATHETER. THE PT EXPIRED. AN UPDATE RECEIVED ON (B)(6) 2014 REPORTED THAT THE MD STATED THE EVENT DID NOT CONTRIBUTE TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527962 CATH PKGD: THERMISTOR 7.5 110CM BALLOON THERODILUTION CATHETER DYG ARROW INTERNATIONAL INC. MF2090522

    Patients

    Seq Age Sex Outcome Treatment
    1